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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: COVIDIEN, FORMERLY USSC PUERTO RICO INC ENDO CLINCH* II 5MM INSTRUMENT LAPAROSCOPE, GENERAL & PLASTIC SURGERY

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COVIDIEN, FORMERLY USSC PUERTO RICO INC ENDO CLINCH* II 5MM INSTRUMENT LAPAROSCOPE, GENERAL & PLASTIC SURGERY Back to Search Results
Model Number 174317
Device Problem Component Falling (1105)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 12/02/2016
Event Type  malfunction  
Manufacturer Narrative
(b)(4).
 
Event Description
According to the reporter, the jaw of the endoclinch broke off inside the patient after only a couple of minutes of usage. He said that it was a clean break and that he was 100% certain that they had retrieved the part that fell into the patient. The staff then opened a new one and continued the operation. There was no negative impact on the patient, no excessive time added to the operation and no blood loss or tissue damage.
 
Manufacturer Narrative
(b)(4). Device has been received but evaluation not yet begun. A supplemental report will be sent upon completion of investigation.
 
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Type of DeviceLAPAROSCOPE, GENERAL & PLASTIC SURGERY
Manufacturer (Section D)
COVIDIEN, FORMERLY USSC PUERTO RICO INC
building 911-67
sabanetas industrial park
ponce PR 00731
Manufacturer (Section G)
COVIDIEN, FORMERLY USSC PUERTO RICO INC
building 911-67
sabanetas industrial park
ponce PR 00731
Manufacturer Contact
sharon murphy
60 middletown ave
north haven, CT 
2034926373
MDR Report Key6241058
MDR Text Key64586172
Report Number2647580-2017-00032
Device Sequence Number1
Product Code HAD
Combination Product (y/n)N
Reporter Country CodeAS
PMA/PMN Number
K903205
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,user facility
Reporter Occupation
Type of Report Initial,Followup
Report Date 12/16/2016
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received01/11/2017
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date07/31/2021
Device Model Number174317
Device Catalogue Number174317
Device Lot NumberP6G0255PX
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer01/24/2017
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received01/24/2017
Was Device Evaluated by Manufacturer? No
Date Device Manufactured07/01/2016
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

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